113. 筋ジストロフィー Muscular dystrophy Clinical trials / Disease details
臨床試験数 : 646 / 薬物数 : 471 - (DrugBank : 105) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 170
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2016-000602-10-BG (EUCTR) | 10/03/2020 | 07/01/2020 | A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroids | A Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Raxone Product Name: Idebenone INN or Proposed INN: IDEBENONE Other descriptive name: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;Spain;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden | ||
| 2 | EUCTR2017-004279-30-NL (EUCTR) | 23/01/2020 | 16/05/2018 | A clinical study to assess the long-term safety and efficacy of idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study. | A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study - SIDEROS-E | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Raxone Product Name: Idebenone INN or Proposed INN: IDEBENONE Other descriptive name: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;France;Spain;Belgium;Austria;Israel;Germany;Netherlands;United Kingdom;Switzerland;Italy;Sweden | ||
| 3 | EUCTR2017-004279-30-AT (EUCTR) | 15/02/2019 | 04/01/2019 | A clinical study to assess the long-term safety and efficacy of idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study. | A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study - SIDEROS-E | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Raxone Product Name: Idebenone INN or Proposed INN: IDEBENONE Other descriptive name: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;France;Spain;Belgium;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 4 | EUCTR2017-004279-30-ES (EUCTR) | 21/12/2018 | 16/11/2018 | A clinical study to assess the long-term safety and efficacy of idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study. | A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study - SIDEROS-E | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Raxone Product Name: Idebenone INN or Proposed INN: IDEBENONE Other descriptive name: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;France;Belgium;Spain;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 5 | EUCTR2016-000602-10-HU (EUCTR) | 18/12/2018 | 05/11/2018 | A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroids | A Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Raxone Product Name: Idebenone INN or Proposed INN: IDEBENONE Other descriptive name: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;Spain;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden | ||
| 6 | EUCTR2017-004279-30-GB (EUCTR) | 26/10/2018 | 09/05/2018 | A clinical study to assess the long-term safety and efficacy of idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study. | A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study - SIDEROS-E | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Raxone Product Name: Idebenone INN or Proposed INN: IDEBENONE Other descriptive name: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;France;Spain;Belgium;Austria;Israel;Netherlands;Germany;Switzerland;Italy;United Kingdom;Sweden | ||
| 7 | EUCTR2017-004279-30-IT (EUCTR) | 29/08/2018 | 22/01/2021 | A clinical study to assess the long-term safety and efficacy of idebenonetreatment in patients with Duchenne Muscular Dystrophy (DMD) whocompleted the SIDEROS study. | A Phase III Open-Label Extension Study to Assess the Long-Term Safetyand Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy(DMD) who completed the SIDEROS study - SIDEROS-E | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Raxone Product Name: Idebenone Product Code: [Idebenone] INN or Proposed INN: IDEBENONE | SANTHERA PHARMACEUTICALS | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | France;United States;Spain;Belgium;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 8 | NCT03603288 (ClinicalTrials.gov) | July 4, 2018 | 31/5/2018 | Phase III Study With Idebenone in Patients With Duchenne Muscular Dystrophy (SIDEROS-E) | A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Who Completed the SIDEROS Study | Duchenne Muscular Dystrophy | Drug: idebenone 150 mg film-coated tablets | Santhera Pharmaceuticals | NULL | Terminated | 11 Years | N/A | Male | 161 | Phase 3 | United States;Austria;Belgium;France;Germany;Italy;Spain;Switzerland;United Kingdom |
| 9 | EUCTR2017-004279-30-BE (EUCTR) | 14/06/2018 | 04/05/2018 | A clinical study to assess the long-term safety and efficacy of idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study. | A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study - SIDEROS-E | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Raxone Product Name: Idebenone INN or Proposed INN: IDEBENONE Other descriptive name: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;France;Spain;Belgium;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 10 | EUCTR2016-000602-10-NL (EUCTR) | 26/04/2017 | 20/09/2016 | A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroids | A Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Raxone Product Name: Idebenone INN or Proposed INN: IDEBENONE Other descriptive name: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Belgium;Bulgaria;Netherlands;Germany;Sweden | ||
| 11 | EUCTR2016-000602-10-GB (EUCTR) | 28/12/2016 | 23/09/2016 | A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroids | A Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Raxone Product Name: Idebenone INN or Proposed INN: IDEBENONE Other descriptive name: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;Spain;Ireland;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Belgium;Bulgaria;Netherlands;Germany;Sweden | ||
| 12 | EUCTR2016-000602-10-AT (EUCTR) | 21/12/2016 | 01/12/2016 | A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroids | A Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Raxone Product Name: Idebenone INN or Proposed INN: IDEBENONE Other descriptive name: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden | ||
| 13 | EUCTR2016-000602-10-ES (EUCTR) | 20/12/2016 | 18/11/2016 | A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroids | A Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS | Duchenne Muscular Dystrophy (DMD) MedDRA version: 19.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Raxone Product Name: Idebenone INN or Proposed INN: IDEBENONE Other descriptive name: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden | ||
| 14 | EUCTR2016-000602-10-FR (EUCTR) | 25/11/2016 | 12/01/2017 | A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroids | A Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS | Duchenne Muscular Dystrophy (DMD) MedDRA version: 19.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Raxone Product Name: Idebenone INN or Proposed INN: IDEBENONE Other descriptive name: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;Spain;Ireland;Austria;Switzerland;United Kingdom;Italy;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden | ||
| 15 | EUCTR2016-000602-10-DE (EUCTR) | 17/11/2016 | 30/05/2016 | A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroids | A Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Raxone Product Name: Idebenone INN or Proposed INN: IDEBENONE Other descriptive name: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden | ||
| 16 | EUCTR2016-000602-10-IT (EUCTR) | 20/10/2016 | 06/02/2018 | A clinical study to assess how effective and safe is idebenone treatment inpatients with Duchenne Muscular Dystrophy (DMD) who are currentlyreceiving Glucocorticoid steroids | A Phase III Double-blind, Randomized, Placebo-Controlled Studyassessing the Efficacy, Safety and Tolerability of Idebenone inPatients with Duchenne Muscular Dystrophy Receiving GlucocorticoidSteroids - SIDEROS | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RAXONE - 150 MG- COMPRESSE RIVESTITE CON FILM- USO ORALE- FLACONE (HDPE)- 180 COMPRESSE INN or Proposed INN: IDEBENONE Other descriptive name: IDEBENONE | SANTHERA PHARMACEUTICALS | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 266 | Phase 3 | France;United States;Belgium;Spain;Austria;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 17 | EUCTR2016-000602-10-BE (EUCTR) | 02/09/2016 | 19/07/2016 | A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroids | A Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Raxone Product Name: Idebenone INN or Proposed INN: IDEBENONE Other descriptive name: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden | ||
| 18 | NCT02814019 (ClinicalTrials.gov) | September 2016 | 17/6/2016 | A Phase III Double-blind Study With Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Taking Glucocorticoid Steroids | A Phase III Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy, Safety and Tolerability of Idebenone in Patients With Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids | Duchenne Muscular Dystrophy (DMD) | Drug: Idebenone 150 mg film-coated tablets;Drug: placebo | Santhera Pharmaceuticals | NULL | Terminated | 10 Years | N/A | Male | 255 | Phase 3 | United States;Austria;Belgium;Bulgaria;France;Germany;Hungary;Ireland;Israel;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom |
| 19 | NCT03433807 (ClinicalTrials.gov) | January 29, 2013 | 8/2/2018 | Expanded Access Program for Idebenone in Participants With Duchenne Muscular Dystrophy (DMD) | Expanded Access Protocol (EAP) of Idebenone in Patients With Duchenne Muscular Dystrophy | Duchenne Muscular Dystrophy | Drug: Idebenone | Santhera Pharmaceuticals | NULL | Temporarily not available | 8 Years | N/A | All | United States | ||
| 20 | EUCTR2009-012037-30-ES (EUCTR) | 27/06/2012 | 29/03/2012 | Hereditary neuromuscular disease | A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 ? 18 Year Old Patients with Duchenne Muscular Dystrophy - DELOS | Duchenne Muscular Dystrophy MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Idebenone Product Code: SNT-MC17 INN or Proposed INN: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 280 | Phase 3 | France;United States;Belgium;Spain;Austria;Netherlands;Germany;Italy;Switzerland;Sweden | ||
| 21 | EUCTR2009-012037-30-IT (EUCTR) | 27/03/2012 | 26/04/2012 | (DELOS) DuchEnne MD Long-term IdebenOne Study | A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 – 18 Year Old Patients with Duchenne Muscular Dystrophy - DELOS | Duchenne Muscular Dystrophy MedDRA version: 14.1;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Idebenone Product Code: NA INN or Proposed INN: IDEBENONE | SANTHERA PHARMACEUTICALS (SWITZERLAND) LTD | NULL | Not Recruiting | Female: no Male: yes | 280 | Phase 3 | France;United States;Canada;Spain;Belgium;Austria;Netherlands;Germany;Italy;Sweden | ||
| 22 | EUCTR2009-012037-30-NL (EUCTR) | 03/06/2010 | 17/12/2009 | Hereditary neuromuscular disease | A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 – 18 Year Old Patients with Duchenne Muscular Dystrophy - DELOS | Duchenne Muscular Dystrophy MedDRA version: 17.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Idebenone Product Code: SNT-MC17 INN or Proposed INN: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;France;Spain;Belgium;Austria;Germany;Netherlands;Switzerland;Italy;Sweden | ||
| 23 | EUCTR2009-012037-30-AT (EUCTR) | 10/03/2010 | 10/02/2010 | Hereditary neuromuscular disease | A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 – 18 Year Old Patients with Duchenne Muscular Dystrophy - DELOS | Duchenne Muscular Dystrophy MedDRA version: 17.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Idebenone Product Code: SNT-MC17 INN or Proposed INN: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | France;United States;Belgium;Spain;Austria;Netherlands;Germany;Italy;Switzerland;Sweden | ||
| 24 | EUCTR2009-012037-30-SE (EUCTR) | 23/02/2010 | 28/12/2009 | Hereditary neuromuscular disease | A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 – 18 Year Old Patients with Duchenne Muscular Dystrophy - DELOS | Duchenne Muscular Dystrophy MedDRA version: 17.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Idebenone Product Code: SNT-MC17 INN or Proposed INN: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | France;United States;Belgium;Spain;Austria;Netherlands;Germany;Italy;Switzerland;Sweden | ||
| 25 | EUCTR2009-012037-30-FR (EUCTR) | 19/02/2010 | 17/12/2009 | A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 – 18 Year Old Patients with Duchenne Muscular Dystrophy - DELOS | A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 – 18 Year Old Patients with Duchenne Muscular Dystrophy - DELOS | Duchenne Muscular Dystrophy MedDRA version: 12.0;Level: LLT;Classification code 10013801;Term: Duchenne muscular dystrophy | Product Name: Idebenone Product Code: SNT-MC17 INN or Proposed INN: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 240 | Phase 3 | Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | ||
| 26 | EUCTR2009-012037-30-DE (EUCTR) | 08/10/2009 | 07/08/2009 | Hereditary neuromuscular disease | A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 – 18 Year Old Patients with Duchenne Muscular Dystrophy - DELOS | Duchenne Muscular Dystrophy MedDRA version: 17.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Idebenone Product Code: SNT-MC17 INN or Proposed INN: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;France;Spain;Belgium;Austria;Netherlands;Germany;Switzerland;Italy;Sweden | ||
| 27 | EUCTR2009-012037-30-BE (EUCTR) | 14/07/2009 | 27/05/2009 | Hereditary neuromuscular disease | A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10 – 18 Year Old Patients with Duchenne Muscular Dystrophy - DELOS | Duchenne Muscular Dystrophy MedDRA version: 17.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Idebenone Product Code: SNT-MC17 INN or Proposed INN: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;France;Spain;Belgium;Austria;Netherlands;Germany;Switzerland;Italy;Sweden | ||
| 28 | NCT01027884 (ClinicalTrials.gov) | July 2009 | 8/12/2009 | Phase III Study of Idebenone in Duchenne Muscular Dystrophy (DMD) | A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10-18 Year Old Patients With Duchenne Muscular Dystrophy | Muscular Dystrophy, Duchenne;Ambulatory Care | Drug: Placebo;Drug: Idebenone | Santhera Pharmaceuticals | NULL | Completed | 10 Years | 18 Years | Male | 65 | Phase 3 | United States;Austria;Belgium;France;Germany;Italy;Netherlands;Spain;Sweden;Switzerland |
| 29 | NCT00758225 (ClinicalTrials.gov) | September 2008 | 23/9/2008 | Long-term Safety, Tolerability and Efficacy of Idebenone in Duchenne Muscular Dystrophy (DELPHI Extension) | A Phase II Open-label Extension Study to Obtain Long-term Safety, Tolerability and Efficacy Data of Idebenone in the Treatment of Duchenne Muscular Dystrophy - Extension to Study SNT-II-001 | Duchenne Muscular Dystrophy | Drug: Idebenone | Santhera Pharmaceuticals | NULL | Completed | N/A | N/A | Male | 21 | Phase 2 | Belgium |
| 30 | EUCTR2007-007752-34-BE (EUCTR) | 14/08/2008 | 26/06/2008 | A Phase II open-label extension study to obtain long-term safety, tolerability and efficacy data of Idebenone in the treatment of Duchenne Muscular Dystrophy | A Phase II open-label extension study to obtain long-term safety, tolerability and efficacy data of Idebenone in the treatment of Duchenne Muscular Dystrophy | Duchennes Muscular Dystrophy MedDRA version: 12.0;Level: LLT;Classification code 10013801;Term: Duchenne muscular dystrophy | Product Name: Idebenone Product Code: SNT-MC17 INN or Proposed INN: Idebenone | Santhera Pharmaceuticals (Switzerland) Ltd | NULL | Not Recruiting | Female: no Male: yes | Phase 2 | Belgium | |||
| 31 | NCT00654784 (ClinicalTrials.gov) | October 2005 | 3/4/2008 | Efficacy and Tolerability of Idebenone in Boys With Cardiac Dysfunction Associated With Duchenne Muscular Dystrophy | A Phase IIa Double Blind, Randomised, Placebo Controlled, Single Centre Study at the University of Leuven to Assess the Efficacy and Tolerability of Idebenone in 8 - 16 Year Old Males With Cardiac Dysfunction Associated With Duchenne Muscular Dystrophy | Duchenne Muscular Dystrophy (DMD) | Drug: idebenone;Drug: placebo | Santhera Pharmaceuticals | NULL | Completed | 8 Years | 16 Years | Male | 21 | Phase 2 | Belgium |
| 32 | EUCTR2005-002520-33-BE (EUCTR) | 06/09/2005 | 04/10/2005 | A Phase IIa double blind, randomised, placebo controlled, single centre study at the university of Leuven to assess the efficacy and tolerability of idebenone in 10 - 16 year old males with cardiac dysfunction associated with Duchenne Muscular Dystrophy | A Phase IIa double blind, randomised, placebo controlled, single centre study at the university of Leuven to assess the efficacy and tolerability of idebenone in 10 - 16 year old males with cardiac dysfunction associated with Duchenne Muscular Dystrophy | Duchenne Muscular Dystrophy | Product Name: idebenone | Santhera Pharmaceuticals LLC | NULL | Not Recruiting | Female: no Male: yes | 21 | Phase 2 | Belgium | ||
| 33 | EUCTR2016-000602-10-IE (EUCTR) | 06/02/2018 | A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroids | A Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Raxone Product Name: Idebenone INN or Proposed INN: IDEBENONE Other descriptive name: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;Spain;Ireland;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden | |||
| 34 | EUCTR2017-004279-30-DE (EUCTR) | 11/06/2018 | A clinical study to assess the long-term safety and efficacy of idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study. | A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study - SIDEROS-E | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Raxone Product Name: Idebenone INN or Proposed INN: IDEBENONE Other descriptive name: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;France;Spain;Belgium;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | |||
| 35 | EUCTR2017-004279-30-SE (EUCTR) | 15/05/2018 | A clinical study to assess the long-term safety and efficacy of idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study. | A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study - SIDEROS-E | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Raxone Product Name: Idebenone INN or Proposed INN: IDEBENONE Other descriptive name: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;France;Spain;Belgium;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | |||
| 36 | EUCTR2017-004279-30-FR (EUCTR) | 14/05/2018 | A clinical study to assess the long-term safety and efficacy of idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study. | A Phase III Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy (DMD) who completed the SIDEROS study - SIDEROS-E | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Raxone Product Name: Idebenone INN or Proposed INN: IDEBENONE Other descriptive name: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | NA | Female: no Male: yes | 266 | Phase 3 | United States;France;Spain;Belgium;Austria;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | |||
| 37 | EUCTR2016-000602-10-SE (EUCTR) | 22/09/2016 | A clinical study to assess how effective and safe is idebenone treatment in patients with Duchenne Muscular Dystrophy (DMD) who are currently receiving Glucocorticoid steroids | A Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids - SIDEROS | Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Raxone Product Name: Idebenone INN or Proposed INN: IDEBENONE Other descriptive name: IDEBENONE | Santhera Pharmaceuticals (Switzerland) Limited | NULL | Not Recruiting | Female: no Male: yes | 266 | Phase 3 | United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Belgium;Bulgaria;Germany;Netherlands;Sweden |